Stereotactic ablative body radiotherapy (SABR), or stereotactic body radiotherapy (SBRT), is a specialized form of radiotherapy used to treat prostate cancer with five treatments over two weeks, compared with a conventional eight-week or longer treatment course. The purpose of this trial is to investigate the effect that proton-based SABR has on quality-of-life in patients with localized prostate cancer. The evaluation and treatment will otherwise follow standard of care, and is not considered investigational.
Patients with low-risk or intermediate-risk, clinically localized prostate cancer will be evaluated according to standard of care medical practices. The evaluation includes history and examination, prostate-specific antigen (PSA) blood testing, and review of the prior prostate biopsy pathology report; radiology scans (for example, computed tomography \[CT\], magnetic resonance imaging \[MRI\], radionuclide bone scan) may be done also; recently completed testing may not need to be repeated. Small markers will be placed in the prostate to guide the proton beam stereotactic ablative body radiotherapy (SABR) treatments, and a hydrogel spacer may also be placed between the prostate and the rectum to push the rectum away from the prostate; the hydrogel spacer will dissolve a few months later. Participants will receive five (5) proton SABR treatments over a two (2) week time period. The study will have participants complete a quality-of life questionnaire and be evaluated for side-effects before starting SABR, at the end of SABR, at three (3), six (6) and 12 months after SABR, and then yearly for five (5) years. Evaluation of the cancer status will follow standard of care practices for at least ten (10) years.
Study Type
OBSERVATIONAL
Enrollment
150
Proton beam
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Adverse Events
Will be assessed by the number of late grade ≥3 Gastrointestinal and Renal and Urinary/Genitourinary adverse event incidents recorded at 24 months after SABR
Time frame: 24 months
Biochemical (PSA) failure
Assessed as time from registration until the date prostate-specific antigen value is ≥ prostate-specific antigen nadir + 2.0 ng/mL estimated by the Gray cumulative incidence method.
Time frame: 120 months
Quality of life - EPIC
ssessed as time from registration until the date prostate-specific antigen value is ≥ prostate-specific antigen nadir + 2.0 ng/mL estimated by the Gray cumulative incidence method.. The EPIC consists of 13 questions answered on varying 5-point scales (e.g., Very Poor/Non to Very Good or No Problem to Big Problem). Subdomains for urinary, bowel, and sexual function will be summarized descriptively. Changes across time will be evaluated to assess patient function and quality of life after study treatment.
Time frame: Baseline; 120 months
Overall survival
Overall survival is defined as the length of time participants are alive after the start of treatment.
Time frame: 120 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.